A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 2 Diabetes When Given by an Insulin Pump

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: NNC0471-0119 H; Drug: Insulin Aspart

• Registration Number: NCT07068295
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study looks at the effect and safety of a new fast-acting insulin (NNC0471-0119) in people with type 2 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters bloodstream, how long it stays there and how much it lowers blood sugar. The new insulin NNC0471-0119 will be compared to insulin aspart. The study will last for about 13-67 days (or a half to 2 months).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-07
• Last Update Submitted: 2025-07-07
• Study Start: 2025-07-10
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Primary Completion: 2025-08-21
• Study Completion: 2026-01-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Male or female (sex at birth).
• Age 18-69 years (both inclusive) at the time of signing the informed consent.
• Diagnosed with Type 2 Diabetes (T2D) greater than or equal to (≥) 180 days before screening.
• Treated with any injectable insulin, except once-weekly insulin, ≥ 180 days before screening.
• Current daily insulin treatment between 0.2 and 1.2 Insulin units per kilogram per day [(I) U/kg/day] (both inclusive) with or without the following anti-diabetic drugs with stable doses ≥ 90 days prior to the day of screening:
• Any metformin formulation
• Dipeptidyl peptidase-4 inhibitor (DPP4i)
• Sodium-glucose Cotransporter-2 inhibitor (SGLT2i)
• Body mass index (BMI) between 18.5 and 34.9 kg/m2 (both inclusive) at screening.
• HbA1c lesser than or equal to (≤) 9.5%

Exclusion Criteria

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NNC0471-0119 H then Insulin Aspart	NNC0471-0119 H	Participants will receive NNC0471-0119 H subcutaneously (s.c.) in period 1 followed by insulin aspart s.c. in period 2.
NNC0471-0119 H then Insulin Aspart	Insulin Aspart	Participants will receive NNC0471-0119 H subcutaneously (s.c.) in period 1 followed by insulin aspart s.c. in period 2.
Insulin Aspart then NNC0471-0119 H	NNC0471-0119 H	Participants will receive insulin aspart s.c. in period 1 followed by s.c. NNC0471-0119 H in period 2.
Insulin Aspart then NNC0471-0119 H	Insulin Aspart	Participants will receive insulin aspart s.c. in period 1 followed by s.c. NNC0471-0119 H in period 2.

Primary Outcome Measures

Name	Time	Method
AUC(GIR,0-1h,basal-corrected): Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to 1 hour	0 to 1 hour after bolus infusion	Measured in milligram per kilogram (mg/kg).

Secondary Outcome Measures

Name	Time	Method
AUC(GIR,0-t,basal-corrected): Area under the basal-corrected GIR-time curve from 0 to t	0 to 11 hours after bolus infusion	Measured in mg/kg.
AUC(GIR,0-1h,basal-corrected)/AUC(GIR,0-t,basal-corrected): Ratio of the area under the basal-corrected GIR-time curve from 0 to 1 hour and 0 to t	0 to 11 hours after bolus infusion	Measured in percentage (%).
GIR (max,basal-corrected): Maximum observed basal-corrected GIR	0 to 11 hours after bolus infusion	Measured in milligrams per (kilogram \*minute) (mg/\[kg\*min\]).
AUC(NNC0471-0119,0-30min,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected): Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 0 to 30 minutes and 0 to t	0 to 11 hours after bolus infusion	Measured in %.
AUC(NNC0471-0119,0-t,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to t	0 to 11 hours after bolus infusion	Measured in hours\*picomole per liter (h\*pmol/L).
AUC(NNC0471-0119,0-30min,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to 30 minutes	0 to 30 minutes after bolus infusion	Measured in h\*pmol/L.
AUC(NNC0471-0119,2h-t,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 2 hours to t	2 to 11 hours after bolus infusion	Measured in h\*pmol/L.
AUC(NNC0471-0119,2h-t,basal-corrected)/AUC(NNC0471-0119 H,0-t,basal-corrected): Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 2 hours to t and 0 to t	0 to 11 hours after bolus infusion	Measured in %.
C(max,NNC0471-0119,basal-corrected): Maximum observed basal-corrected serum NNC0471-0119 concentration	0 to 11 hours after bolus infusion	Measured in picomoles per litre (pmol/L).
t(early50%Cmax,NNC0471-0119,basal-corrected): Time to early 50% maximum observed basal-corrected serum NNC0471-0119 concentration	0 to 11 hours after bolus infusion	Measured in minutes (Min).
t(late50%Cmax,NNC0471-0119,basal-corrected): Time to late 50% maximum observed basal-corrected serum NNC0471-0119 concentration	0 to 11 hours after bolus infusion	Measured in min.
Number of adverse events (AEs)	From start of first investigational medicinal product (IMP) basal rate infusion (day -1) until completion of post-treatment end of study visit (up to 67 days)	Measure in number of events.

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany